ClinicalTrials.gov Registration

To register your trial:

Request an account for the ClinicalTrials.gov Protocol Registration and Results System by emailing the local ClinicalTrials.gov Administrator, Ellen Ciesielski. The message should be sent by the person who will be creating the Protocol Record for a clinical trial, i.e., the PI or the PI’s designee. A Protocol Record can have only one “Owner.”

Complete the login fields. If you are a UConn Health investigator, in the “Organization” field, type “UConnHealth.” If you are a UConn Storrs or Regional Campus investigator, in the “Organization field, type “UConn.”

Browse the Main Menu page. Under “User Account,” follow the instructions for changing your temporary password as soon as possible. Save your password; you will need it for periodic updates and verification. Under “Help”, refer to the “User’s Guide” for additional information. As the PI, or PI designee, you are a User and are responsible for entering the information about your trial, ensuring that the information is correct, and updating the information in a timely manner (for updating, see NOTE at the end of this section).

On the Main Menu page, under “Protocol Record” click on “Create” and complete the study description template. Note that required fields are marked with

* [a red asterisk] = required by ClinicalTrials.gov

FDAAA [in green] = required to comply with US Public Law 110-85, Section 801

(FDAAA) [in green] = may be required to comply with US Public Law 110-85, Section 801

Work your way through the data fields to complete the Protocol Record. Data are saved as each screen is filled in, so that you can “Quit” at any time, saving the Record for later completion using “Modify.”

Conditions: Use the MeSH controlled vocabulary. If you don’t, ClinicalTrials.gov staff is likely to delete your term and choose one of their own.

Keywords: Use the MeSH controlled vocabulary. If you don’t, ClinicalTrials.gov staff is likely to delete your term and choose one of their own.

Investigators: list all investigators on the approved IRB protocol.

Automatic messages from the electronic system:

WARNING: indicates a data element required by the FDA Amendments Act of 2007 has not been entered.

ERROR: indicates a serious problem that needs to be addressed

ALERT: indicates a problem that needs to be addressed; generally that problem is a missing data element required by ICMJE

NOTE: indicates a potential problem that should be reviewed and corrected, as needed

Protocol Records must be free of the first three messages in order to be approved and released to ClinicalTrials.gov for processing and publication

To maintain your record and remain in compliance with the Final Rule, you must update the data fields on the schedule detailed in the table:

Data Field

Deadline for Updating
(i.e., not later than the specified date)

Study Start Date

30 calendar days after the first subject is enrolled (if the first human subject was not enrolled at the time of registration).

Intervention Name(s)

30 calendar days after a nonproprietary name is established.

Availability of Expanded Access

30 calendar days after expanded access becomes available (if available after registration); and 30 calendar days after an NCT number is assigned to a newly created expanded access record. [1]

Expanded Access Status

30 calendar days after a change in the availability of expanded access.

Expanded Access Type

30 calendar days after a change in the type(s) of available expanded access.

Overall Recruitment Status

30 calendar days after a change in overall recruitment status. [2]

Individual Site Status

30 calendar days after a change in status of any individual site.

Human Subjects Protection Review Board Status

30 calendar days after a change in status.

Primary Completion Date

30 calendar days after the clinical trial reaches its actual primary completion date.

Enrollment

At the time the primary completion date is changed to “actual,” the actual number of participants enrolled must be submitted.

Study Completion Date

30 calendar days after the clinical trial reaches its actual study completion date.

Responsible Party, by Official Title

30 calendar days after a change in the responsible party or the official title of the responsible party.

Responsible Party Contact Information

30 calendar days after a change in the responsible party or the contact information for the responsible party.

Device Product Not Approved or Cleared by U.S. FDA

15 calendar days after a change in approval or clearance status has occurred.

Device Product Not Approved or Cleared by U.S. FDA

15 calendar days after a change in approval or clearance status has occurred.

Record Verification Date

Any time the responsible party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time.

[1] If expanded access to an investigational drug product becomes available after a clinical trial of that drug product has been registered and an expanded access record has not yet been created, a responsible party who is both the manufacturer of the investigational product and the sponsor of the applicable clinical trial must also, not later than 30 calendar days after expanded access becomes available, submit the data elements in accordance with 42 CFR 11.28(c) to create an expanded access record.[2] If Overall Recruitment Status is changed to “suspended,” “terminated,” or “withdrawn,” the Why Study Stopped data element must be submitted at the time the update is made.

Who do I contact if I have questions?

Contact Ellen Ciesielski, local ClinicalTrials.gov Administrator, at 860-679-6004 or eciesielski@uchc.edu.